n.a. 27040GPB1-SRecalls & reported problems
Karl Storz GmbH & Co. KG · CUTTING LOOP, BIPOLAR, 27/28 FR. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551393529), received between Apr 3, 2020 and May 1, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
- Material Twisted/Bent1
- Output Problem1
- Unexpected Therapeutic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Unexpected Therapeutic Results; Material Twisted/Bent; Output Problem; Unexpected Therapeutic Results; Material Twisted/Bent; Output Problem
IT WAS REPORTED THE PETAL WAS USED IT WAS NOT CUTTING OR STOPPING THE BLEEDING. THE LOOP BENT DUE TO NO CUTTING AND PUSHING AGAINST THE TISSUE THERE WAS NO DELAYED IN THE CASE. NO HARM TO PATIENT. THERE WAS NO GLOW AT ALL ON THE CUTTING LOOP. CROSS REFERENCE COMPLAINT ID (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944056 ↗MalfunctionApr 3, 2020Material Separation; Material Separation
ALLEGEDLY PER THE CUSTOMER, DURING A UROLOGY PROCEDURE, THE ENTIRE LOOP DISENGAGED FROM THE WORKING ELEMENT AND CAME OUT OF THE SHEATH INSIDE THE PATIENT. THE BROKEN PART OF THE ELECTRODE WAS SAFELY REMOVED WITH NO HARM TO THE PATIENT. THE ELECTRODE WAS REPLACED AND THE PROCEDURE COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9920618 ↗
Other ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL devices
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.